Privatsphäre-Einstellungen

Integration von Änderungs- und Risikomanagement- Prozessen in den Lebenszyklus von Arzneimitteln

Änderungen an Produkten und Herstellungsprozessen dokumentieren, kommunizieren und umsetzen

Dr. Karin Ammon und Claudia Lange

PLATO AG, Dortmund

Documentation, communication and implementation of Changes in Product or Manufacturing Process by Means of Risk Management.

It becomes evident, setting a trend in the early phases of developing complex pharmaceutical products is paving the way for success or failure of the whole project. Absence of business and project objectives, not focused product requirements and uncoordinated modifications during the progression of product and process engineering are playing a decisive role for the failure of projects.
An effective risk management is attending a pharmaceutical product during its whole life cycle process and is therefore providing an optimal potential to include a product / manufacturing process modification, to communicate the modification and to provide a risk based basis of decision-making.
The following article is representing the integration of change and risk management. For this purpose, necessary business processes shall be synchronised and an accompanying development method is getting introduced (DRBFM, Design Review Based On Failure Mode).
This method has the objective to be an integral part of the development and risk management process. The benefit of a database-based software solution is to rea lise a complete tracking of activities and knowledge management in practise.